Cellular therapy (also called cell therapy) can be defined as an approach that inject or implant cellular materials such as human cells from a donor or animal cells used to cure illness into a patient. Now, as cell therapies promise to cure many types of diseases, there is a large of pressure to require rapid regulatory approval. Since there is no "one size fits all" regulatory approach for different cellular therapies, CD BioSciences is dedicated to providing tailored clinical studies depending on the characteristics of specific product.
We will cooperate with our clients in the every stage of clinical trials from early phase through late phase, providing a thorough trial plan, select appropriate subjects and site, and monitor the whole test process.
Fig.1 System for delivering individualized, autologous, ex vivo, cellular therapies. (Elverum, Kris, and Maria Whitman, 2019)
Your product has the potential to become life-changing treatment, our task is to help you bring it to the market in shortest time. CD BioSciences is dedicated to providing comprehensive suite of clinical development services to anticipate challenges, overcome obstacles so that facilitate your cellular therapy development program. If you are interested in our services, please feel free to contact us to discuss how we can be involved in your cellular therapy development program.
1. Au, Patrick, et al. "FDA oversight of cell therapy clinical trials." Science translational medicine 4.149 (2012): 149fs31-149fs31.
2. Elverum, Kris, and Maria Whitman. "Delivering cellular and gene therapies to patients: solutions for realizing the potential of the next generation of medicine." Gene therapy (2019): 1-8.
3. Schulman, Ivonne H., et al. "Unique Aspects of the Design of Phase I/II Clinical Trials of Stem Cell Therapy." The Management of Clinical Trials (2018): 55.